TY - JOUR
T1 - Medical record review of transition to lanreotide following octreotide for neuroendocrine tumors
AU - Saif, Muhammad Wasif
AU - Parikh, Rohan
AU - Ray, David
AU - Kaye, James A.
AU - Kurosky, Samantha K.
AU - Thomas, Katharine
AU - Ramirez, Robert A.
AU - Halfdanarson, Thorvardur R.
AU - Beveridge, Thomas J.R.
AU - Mirakhur, Beloo
AU - Nagar, Saurabh P.
AU - Soares, Heloisa P.
N1 - Funding Information:
This work was supported by IPSEN through a research
Funding Information:
Conflicts of Interest: At the time the study was conducted, R Parikh, SK Kurosky, JA Kaye, and S Nagar were full-time employees of RTI Health Solutions, which received research funding from IPSEN Biopharmaceuticals, Inc. (IPSEN) to conduct the study. D Ray, T Beveridge, and B Mirakhur were employees of IPSEN at the time of the study. R Ramirez has consulted for Novartis, and Advanced Accelerator Applications, and is a member of the speakers’ bureau for IPSEN, Merck, Guardant Health, Genentech, and Astra-Zeneca. K Thomas has no conflicts of interest to declare. TR Halfdanarson is an advisory board member for Lexicon, and Advanced Accelerator Applications and has received research support from IPSEN, Agios, ArQule, and Thermo Fisher Scientific. H Soares has consulted for IPSEN, Novartis, Bayer, and Lexicon.
Publisher Copyright:
© Journal of Gastrointestinal Oncology. All rights reserved.
PY - 2019
Y1 - 2019
N2 - Background: Octreotide has been used for decades in the United States (US) and Europe to treat patients with advanced neuroendocrine tumors (NETs). Lanreotide was approved in 2014 to improve progression-free survival (PFS) in patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic NETs. Therefore, clinicians and patients may consider sequencing therapy from octreotide to lanreotide. However, current real-world outcomes data on patients who have made this transition is limited. Methods: We conducted a multicenter, noninterventional, retrospective medical record review of patients with locally advanced or metastatic gastroenteropancreatic NETs (NCT03112694). Included patients had been treated with long-acting octreotide monotherapy for ≥90 days before transitioning to lanreotide monotherapy and continued on lanreotide for ≥90 days. Abstractors entered patient demographic and clinical data into a customized, web-based case report form. We assessed clinically defined PFS and other tumor-related outcomes while patients were treated with lanreotide. Outcomes were analyzed according to level of response at the time of transition from octreotide to lanreotide: progressive disease, nonprogressive disease, or unknown. Statistical analyses were descriptive. Clinically defined PFS and duration of treatment with lanreotide were estimated using the Kaplan-Meier method. Results: Data were abstracted for 91 patients with gastroenteropancreatic NETs who received long-acting octreotide followed by lanreotide at six US based sites. At initial diagnosis, 71.4% of patients had stage IV disease. Small intestine (63.7%) and pancreas (14.3%) were the most common primary tumor sites. Mean [standard deviation (SD)] duration of follow-up from diagnosis was 70.6 (41.3) months. Patients received long-acting octreotide for a mean (SD) of 38.4 (32.8) months. When patients transitioned to lanreotide, 57.1% had nonprogressive disease on octreotide, 30.8% had progressive disease, and the remainder had unknown disease status. The most common reasons for switching from octreotide to lanreotide were progressive disease (22.0%), formulary change (15.4%), and patient preference (9.9%). Patients received lanreotide for a median (95% CI) duration of 24.7 (16.7–59.9) months. At the end of follow-up, 74% of patients remained on lanreotide monotherapy. Progression occurred in 24.2% of patients during lanreotide treatment. Overall median (95% CI) clinician-defined PFS following the transition to lanreotide was estimated to be 23.7 months [20.2 months–NE (not estimable)]. Patients with nonprogressive disease when they transitioned to lanreotide experienced a median clinician-defined PFS of 24.7 (17.0–NE) months. Among patients reported to have progressive disease when they transitioned to lanreotide, median (95% CI) clinician-defined PFS was estimated to be 15.2 (11.4–NE) months. There were no material differences in adverse events recorded during the long-acting octreotide and lanreotide treatment periods. Conclusions: Our study suggests that lanreotide monotherapy is well tolerated and may contribute to stabilization of disease in a subset of patients with locally advanced or metastatic gastroenteropancreatic NETs previously treated with long-acting octreotide.
AB - Background: Octreotide has been used for decades in the United States (US) and Europe to treat patients with advanced neuroendocrine tumors (NETs). Lanreotide was approved in 2014 to improve progression-free survival (PFS) in patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic NETs. Therefore, clinicians and patients may consider sequencing therapy from octreotide to lanreotide. However, current real-world outcomes data on patients who have made this transition is limited. Methods: We conducted a multicenter, noninterventional, retrospective medical record review of patients with locally advanced or metastatic gastroenteropancreatic NETs (NCT03112694). Included patients had been treated with long-acting octreotide monotherapy for ≥90 days before transitioning to lanreotide monotherapy and continued on lanreotide for ≥90 days. Abstractors entered patient demographic and clinical data into a customized, web-based case report form. We assessed clinically defined PFS and other tumor-related outcomes while patients were treated with lanreotide. Outcomes were analyzed according to level of response at the time of transition from octreotide to lanreotide: progressive disease, nonprogressive disease, or unknown. Statistical analyses were descriptive. Clinically defined PFS and duration of treatment with lanreotide were estimated using the Kaplan-Meier method. Results: Data were abstracted for 91 patients with gastroenteropancreatic NETs who received long-acting octreotide followed by lanreotide at six US based sites. At initial diagnosis, 71.4% of patients had stage IV disease. Small intestine (63.7%) and pancreas (14.3%) were the most common primary tumor sites. Mean [standard deviation (SD)] duration of follow-up from diagnosis was 70.6 (41.3) months. Patients received long-acting octreotide for a mean (SD) of 38.4 (32.8) months. When patients transitioned to lanreotide, 57.1% had nonprogressive disease on octreotide, 30.8% had progressive disease, and the remainder had unknown disease status. The most common reasons for switching from octreotide to lanreotide were progressive disease (22.0%), formulary change (15.4%), and patient preference (9.9%). Patients received lanreotide for a median (95% CI) duration of 24.7 (16.7–59.9) months. At the end of follow-up, 74% of patients remained on lanreotide monotherapy. Progression occurred in 24.2% of patients during lanreotide treatment. Overall median (95% CI) clinician-defined PFS following the transition to lanreotide was estimated to be 23.7 months [20.2 months–NE (not estimable)]. Patients with nonprogressive disease when they transitioned to lanreotide experienced a median clinician-defined PFS of 24.7 (17.0–NE) months. Among patients reported to have progressive disease when they transitioned to lanreotide, median (95% CI) clinician-defined PFS was estimated to be 15.2 (11.4–NE) months. There were no material differences in adverse events recorded during the long-acting octreotide and lanreotide treatment periods. Conclusions: Our study suggests that lanreotide monotherapy is well tolerated and may contribute to stabilization of disease in a subset of patients with locally advanced or metastatic gastroenteropancreatic NETs previously treated with long-acting octreotide.
KW - Disease-free survival
KW - Lanreotide
KW - Neuroendocrine tumors/drug therapy
KW - Octreotide
KW - Somatostatin/aa
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UR - http://www.scopus.com/inward/citedby.url?scp=85072623089&partnerID=8YFLogxK
U2 - 10.21037/jgo.2019.03.11
DO - 10.21037/jgo.2019.03.11
M3 - Article
AN - SCOPUS:85072623089
VL - 10
SP - 674
EP - 687
JO - Journal of Gastrointestinal Oncology
JF - Journal of Gastrointestinal Oncology
SN - 2078-6891
IS - 4
ER -